Highest risk U.S. Food and Drug Administration

Ethicon Megadyne Mega Soft Pediatric Patient Return Electrode recall: Reports of patient burn injuries

Recall published 2+ years ago

Reports of patient burn injuries

Ethicon Megadyne Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Fire or burn hazard

A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

What the notice says: A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
May 10, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Ethicon Megadyne
Product type
Medical devices
Reports of harm
Between 2018 and today, there have been 4 reported injuries and no reports of death associated with this product.

Products covered by this recall

Mega Soft Pediatric Patient Return Electrode

What the company announced

Cincinnati, OH – May 10, 2024 – MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.

The combination of these conditions may be more likely when the pad is used with infants and small children. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product.

Between 2018 and today, there have been 4 reported injuries and no reports of death associated with this product. The Company has decided to discontinue and voluntarily recall the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode. U.S. (Food and Drug Administration) FDA has been notified of this action.

Customers who have MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes should stop using them and return them. The recall includes the following product code, which can be identified by name Pediatric Return Electrode Pad shown on the pad.

  • Product Name: MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode · Product Code: 0840 · UDI-DI: 10614559103395

Megadyne is notifying global customers and distributors by mail and is arranging for return of impacted product. Product was distributed in the United States and international markets.

Customer with questions may contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266) Monday through Friday, 8:00 AM to 5:00 PM ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: here

FDA form 3500 available here

Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 0840

Package size

Match the net weight or the piece count on the front of the pack.

  • 50 pounds

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Ethicon Megadyne — A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.
  3. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  4. Do not leave it charging overnight or while the house is empty while you wait for the remedy.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Remedy named in the notice: Customers who have MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes should stop using them and return them.

Company contact: Megadyne Medical Products Inc. — Consumers: Ethicon Resource Department, 1-877-ETHICON (1-877-384-4266)

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ethicon Megadyne medical devices recalled?

Reports of patient burn injuries A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 0840. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

The notice says: Customers who have MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes should stop using them and return them.

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